Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT05720494
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2023-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Sponsor:
Jazz Pharmaceuticals
Organization:
Study Overview
Official Title:
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of JZP441 in Healthy Adult Participants: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies and may represent a novel approach for these patients.
Detailed Description:
This Phase 1, double-blind, randomized, placebo-controlled, parallel group study is designed to characterize the safety, tolerability, and PK of multiple ascending doses of JZP441 for up to 4 weeks in healthy adult participants.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: